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As I understand it, the EPO allows claims to a second medical use of a known substance. These claims are not the same as the formerly used "Swiss-type claims" that were drawn to the use and were therefore method claims.

An example in the EPO rules is:

"Product X for use in the treatment of cancer*

If a substance is previous known, what makes a bottle of it infringe a claim that has to do with an intended use? Sitting on a shelf it is the same substance that was long known. Would it be the labeling of the bottle?, the advertisements of its maker/bottler? I understand that methods of treatment are not patentable in the EPO (unlike in the U.S.). But this seems like form over substance since the intended use is not manifest until the unpatentable use is about to occur.

To the thinking of a practitioner of U.S. patent law it is very illogical for a known substance to be patentable with no physical change.

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    Interesting question. I find 11,495 granted patents associated with the compound "adalimumab" which is the active ingredient in Humira. Many, I assume are new indications (medical application). – Eric S Jul 22 at 19:05
  • In the U.S there are about 5,000 but only about 500 have it in a claim. Lots of them seem to be "methods of treating" and some methods of manufacturing. As an aside, methods of diagnosing are also not patentable in the EPO, but are in the U.S. The U.S. does not allow enf – George White Jul 22 at 22:38
  • In the U.S there are about 5,000 but only about 500 have it in a claim. Lots of them seem to be "methods of treating" and some methods of manufacturing. As an aside, methods of diagnosing are also not patentable in the EPO, but are in the U.S. While these patents are issued,t he U.S. does not allow enforcement against medical profesionals themselves. – George White Jul 22 at 23:36
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European Patents may indeed protect products for a second medical use. The Guidelines explicitly state "known products" for second (or further) medical use. The patent is granted depending on whether the further medical use is inventive over the prior art, because obviously the product itself is not. The reason behind all this is that protection of second medical uses fosters investigation of new ways of treating diseases without having to invent a new compound.

Whoever invents a compound can protect the compound itself if it has some use and is inventive, but can also protect the compound "for medical use" without specifying which disease it cures, thereby having protection for all medical uses. Said claim will be allowable only if it is shown that the compound cures some disease, otherwise the applicant is not entitled to the protection for medical use, so another applicant could take the known compound and protect it "for medical use" should the latter applicant show that it cures a disease. Then, other medical uses of the compound that are deemed inventive can also be protected.

Concerning the actual question, there are no uniform criteria between the Contracting States of the EPC when it comes to enforcement and infringement of second medical use claims. Several good explanations about these legal questions can be found in this article from Finnegan (I am in no way related to Finnegan) that summarizes the attempts of UK Courts to shed some light on the matter. One of the conclusions if not the main conclusion is as follows: "The Court recognised an obligation on a manufacturer to take active steps if it is to enter a market where it stands to benefit from the patentee’s patented invention. In order to avoid infringement, the manufacturer must show that it has taken all reasonable steps in its power to prevent its drug from being used in accordance with the patent."

The labeling and advertisements of the company commercializing the product are very important in the enforcement of the European Patent as you suspected, George White. It would seem in light of the article that this is not enough though, and some additional steps are expected from the company to avoid infringement of a European Patent for a second medical use.

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  • So, in a hypothetical, a substance known for 30 years used to treat X can not be continued to be produced and packaged as it had been for decades becasue of the possibility of it being used to treat Y? I have often told people to not expect patent law to make sense but this is bizarre to a U.S. patent law way of thinking. – George White Jul 23 at 19:24
  • The U.S. approach is that it is not the unchanged substance that is patented but the actual use. However the health care personnel are exempted from enforcement. Their actions do constitute infringement. Therefore a manufacturer, distibutor who encouraged this infringing use might be guilty of contributory infringement. – George White Jul 23 at 19:34
  • I think you would not have a problem in the scenario depicted in your question. You can prove that you have been manufacturing and selling a product for quite some time prior to the protection of the second medical use. The labeling and your history manufacturing/selling the product shows that. Also, many European countries do not find a party to be infringing if they started manufacturing a patented product before the patent became public, it is in their patent law. Doing something in good faith also has some bearing on the outcome of a litigation process. – the Europeist Jul 23 at 20:40
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    @GeorgeWhite I see. What has to be patented in Europe is the product for the further medical use because that precludes the medical staff from infringing, which is why the medical methods cannot be patented in the first place as you pointed out in the question. Whoever was responsible for putting the product on the shelf of the medical staff infringed, be it the manufacturer or the distributor, but the medical staff is free to use it. – the Europeist Jul 23 at 20:49
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    The outcome seems to be almost the same in both systems. – George White Jul 23 at 23:39
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EDIT: Second medical use patents are enforced as products for a give use. So the alleged infringer must have intention the product is used in a certain way to be found liable. What follows is a possibly-off-topic-but-hopefully-useful discussion of how intention might be considered in a second medical use situation. Note that the original question specifically asked about labeling and marketing. So this might seem off topic but actually gets to the heart of what the question is about, even if that's not apparent at first glance.

Excellent question. As pointed out, this has been the subject of some interesting court cases in recent years.

The interplay with the regulation of medicines is important here. In most (perhaps all?) countries a compound cannot be sold as being for the treatment of a disease (i.e., as a medicine) without an appropriate marketing authorization (MA) from the relevant regulator. The MA is for a particular condition or limited set of conditions. This allows you to put on the label (a.k.a., the SmPC or patient information leaflet) what the compound is for, medicinally, and to talk about it as a medicine in your marketing materials, etc.

If you come to know that the compound can be used in a new medical use, then you can't just start selling it for that use. You'd have to have an appropriate MA to update the label to include the new condition, or the regulator would come down on you like a tonne of bricks. If you have the right MA and you advertise the compound as being for the new medical use, then it's pretty clear what your intentions are. The holder of a second medical use patent covering the new use would therefore be able to say that you were selling the compound for the use in their patent: you've pretty much been forced to admit it to avoid heat from the regulator.

But you'd still be free to sell the compound for the use in your original MA, i.e., for the treatment of the old condition. You just can't say it's for treatment of the new condition. You might even manufacture the same product with multiple different versions of the label for different territories, which might be as simple as a sticker that goes on the boxes/bottles that are shipped to a territory where the second medical use is patented. This process is called skinny labeling or label carve-out.

However, where this gets complicated is that although you might never say your product is for the new use, it's possible that doctors will prescribe your product for the new use anyway. This is called off-label prescribing and is a routine thing doctors do.

SECOND EDIT: What if the alleged infringer knows that its product is being used off-label. What if they tacitly encourage it? Are they liable now? This is a complex infringement question that has been reviewed by courts across Europe.

So the position that some courts in Europe have reached is that the manufacturer has to do something to avoid off-label use in order to avoid infringement. Exactly what will depend on the territory.

It should be noted that the Finnegan article linked to in an earlier answer is a little out of date as the UK Supreme Court has since issued a decision on this topic (summary here).

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    This is interesting and as far as I know accurate. However I'm failing to see the connection to patenting and patent law which is the subject of this site. Perhaps you could expand on that or otherwise this answer may get flagged as off topic. – Eric S Aug 26 at 16:40
  • As Eric said - if you are new to stackexchange it is set up to be strictly a Q and A site, not a discussion site. An answer needs to directly address its question. The question was about patents. Anything else should be a comment. In fact, technically a comment should primarily be a way to ask for or provide clarification of a Q or an A. An alternative, if a question gets you thinking about a related but different question, you can post your own question and then answer your own question. – George White Aug 26 at 17:58
  • In my opinion the answer provided gives some interesting insights regarding the enforcement of second medical use claims. This type of claims protect the product, and depending on how you are to commercialize it, the patent owner can enforce the patent rights if you are offering for sale a drug for the second medical use. The labeling plays a key role in all this as discussed by epattorney. – the Europeist Aug 26 at 18:45
  • OK, I had a little go at amending it. Maybe an answer was the wrong way to proceed, I really don't know. I only note that the original question asked if infringement of a second medical use patent had to do with labeling and/or marketing of the product. I'd post a comment but I don't seem to be able to do that. Please do delete the whole thing if it's causing a problem or is distracting. I'd delete it myself but I don't see that option. – epattorney Aug 27 at 9:00
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Yes, during evaluation of infringement of a medical use patents in US or Europe the courts consider only what is present in the PIL(PATENT INFORMATION LEAFLET). It would not look beyond lable, the basis is that the regulatory agencies had reviewed and approved the drug for the indication and any use out side the PIL would attract a flag from regulatory agencies ( eg: Purdue pharma promotion of opioids).

The product can be marked even though there is a patent for new medical use. Statue had proved FDA To approve a product that doesn't have all indications i.e., a product x for an indication Y can be marked, even when there is patent for indication Z.

There are many instances where FDA has authorised generics for one indication when the brand drug has more than one indication. The recent case I would suggest is the case of NORVASC ( PFIZER VS TEVA) this case gives you understanding of lable carving/ skinny lable.

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  • but this does not make any sense, in he U.S (and I assume elsewhere) the courts look at the claims in the patent, not a PIL?? . I see by a google search that a PIL is a patient information packet not a patent information packet. – George White Jul 24 at 21:52
  • Sorry it was a typo it I ment it is patient information pack. I am sorry you feel that is doesn't make sense but it is true for us and Europe. India and china doesn't grant patents for method of use. – RishiM Jul 26 at 1:00

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